The US FDA has granted GlaxoSmithKline (GSK) and Vir Biotechnology an Emergency Use Authorisation (EUA) for sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19.
Specifically, it has approbved for use in adults and paediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death.
Sotrovimab – formally VIR-7831 – has been granted an EUA by the FDA to facilitate the availability and use of this investigational monoclonal antibody for the treatment of COVID-19 in the U.S. while the pandemic remains a public health emergency.
The FDA Fact Sheet for Healthcare Providers regarding the emergency use of sotrovimab reflects the recently updated definition of high risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease.
The EUA for sotrovimab also includes post-authorisation commitments as specified in the Letter of Authorisation.
Sotrovimab is continuing to be studied in ongoing clinical trials. An analysis of safety and efficacy data at day 29 for the full population from the COMET-ICE trial is expected as early as the first half of 2021.
GSK and Vir plan to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.